Business Wire - Tuesday, November 30, 1999
Trimeris Inc. (NASDAQ: TRMS) and Hoffmann-La Roche Inc. announced today that dosing has started in the first clinical study in HIV-positive children to use a new class of anti-HIV drugs known as fusion inhibitors. The trial is being conducted in collaboration with the Division of AIDS of the National Institute for Allergy and Infectious Diseases (NIAID) and will be managed by the Pediatric AIDS Clinical Trial Group (PACTG) to evaluate the safety and pharmacokinetics of T-20 in children living with HIV infection. T-20 is the first member of the fusion inhibitor class of investigational antiretroviral compounds to enter clinical trials. The trial, T20-204 (PACTG 1005), has been designated as a fast-track study within the PACTG system.
"This is the first study of a promising new class of AIDS drug in children, and we are hopeful that T-20 will provide a viable new treatment option for this population," said Coleen Cunningham, M.D. of the State University of New York, Upstate Medical University Syracuse. "Combination antiretroviral therapy has dramatically benefited many HIV infected children, but there are currently many children who are in dire need of new options. This trial is the first step in the assessment of how an entirely new class of HIV fighting drugs may improve the management of pediatric HIV disease." Dr. Cunningham and Joseph Church, M.D. from the Children's Hospital of Los Angeles co-direct the study.
According to recent statistics from the Centers for Disease Control and Prevention (CDC), more than 8,500 children between the ages of three and 13 have been diagnosed with AIDS in the United States, and it is estimated that more than 20,000 U.S. children are HIV-positive. In all, approximately one million Americans are infected with HIV. The CDC estimates that 40,000 to 50,000 new HIV infections occur in the U.S. every year.
"Expanding clinical trials of T-20 to include children is part of our full-scale clinical development program involving fusion inhibitors," said Dani Bolognesi, Ph.D., Chief Executive Officer of Trimeris. "We are committed to exploring the therapeutic potential of fusion inhibitors in a range of populations of people living with HIV."
About the study
The T20-204 (PACTG 1005) study is designed to investigate the safety, tolerability and pharmacokinetics of T-20 in pediatric patients. The trial is a two-part (A and B), Phase I/II, dose escalating, open label, single and chronic dosing study in pediatric patients ages three to 12. Part A will examine safety parameters to establish a well-tolerated pediatric dose that provides target plasma concentrations of T-20. Part B will evaluate the safety and tolerability of T-20 in combination with other antiretroviral agents over a 24-week period. In this study, T-20 will be administered via subcutaneous injections twice daily in conjunction with standard pediatric antiretroviral therapy.
More about T-20
T-20 belongs to a new class of investigational anti-HIV treatments called fusion inhibitors. Unlike existing AIDS drugs that work in the cell to target viral enzymes involved in the replication of the virus, T-20 inhibits fusion of HIV with host cells before the virus begins replicating and infecting other cells.
Previously released sixteen-week data presented in September 1999 at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy showed that 33 of 55 (60%) heavily pre-treated adult patients who were given T-20 in combination with oral antiretroviral agents responded with a clinically significant reduction of HIV in the blood (viral suppression of greater than 1.0 log10 from baseline or below the level of quantification of 400 copies/mL, using the Roche Amplicor Assay). Indeed, 20 of the 55 (36%) had virus levels below the level of quantification (<400 copies/mL).
In all clinical studies to date, the most common adverse events were mild to moderate in severity. The most frequent adverse events include injection site reaction, headache, nausea, fever, increased energy levels, asthenia, diarrhea, and dizziness, although a causal relationship to T-20 cannot be established for some of these results.
In July 1999, Trimeris and Roche signed an agreement for the full-scale clinical testing and development of Trimeris' two novel anti-HIV fusion inhibitors, T-20 and T-1249.
About Trimeris Inc.
Trimeris is a development stage, biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells. Trimeris' lead product candidate, T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells, is currently in Phase II clinical trials and has received fast-track designation from the FDA. Trimeris' second fusion inhibitor product candidate, T-1249, which also inhibits HIV fusion, has received fast-track designation from the FDA and is in Phase I clinical testing.
For more information on Trimeris, Inc., visit the company's web site at: http://www.trimeris.com.
About Hoffmann-La Roche Inc.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology; and metabolic diseases including obesity and diabetes.
For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at: http://www.rocheusa.com.
Trimeris Safe Harbor Statement
Note: Except for any historical information presented herein, matters presented in this release are forward-looking statements that involve risks and uncertainties. The results of Trimeris' previous clinical trials are not necessarily indicative of future clinical trials, and future results could differ materially from the results presented herein. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the "Risk Factors" section included in Trimeris' Form 10-Q for the three months ended March 31, 1999, filed with the Securities and Exchange Commission on May 17, 1999, and the Company's Registration Statement on Form S-3 as declared effective by the Securities and Exchange Commission on May 26, 1999.
CONTACT: Trimeris, Inc., Durham, NC Media: Alex Dusek or Investors: Tim Creech Phone: 919/419-6050 or Hoffmann-La Roche Inc., Nutley, NJ Kellie McLaughlin Phone: 973/562-2231 Pager: 800/946-4645 Pin No. 6438692
991130
BW991110
Copyright © 1999 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 1999. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1999. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .